Table 3.

Trough plasma concentrations of brivaracetam and its metabolites during the evaluation period for patients with focal seizures (pharmacokinetic-per-protocol set)

	Trough plasma concentration (µg/mL)a
	Patients with focal seizuresb
	Aged < 4 years	Aged 4 to < 16 years	Total
End of week 1 (low dose)	n = 11	n = 19	n = 30
Brivaracetamc	0.201 (64.4)	0.279 (81.0)	0.247 (76.3)
BRV-OH	0.050 (78.8)	0.061 (44.7)	0.057 (58.0)
BRV-AC	0.008 (94.4)	0.015 (77.3)	0.012 (89.9)
BRV-OHAC	0.006 (43.1)	0.008 (46.7)	0.007 (48.4)

End of week 2 (mid dose)	n = 9	n = 11	n = 20
Brivaracetamd	0.348 (62.3)	0.379 (58.3)	0.365 (58.5)
BRV-OH	0.100 (63.1)	0.123 (55.3)	0.112 (58.3)
BRV-AC	0.016 (84.9)	0.020 (66.2)	0.018 (73.7)
BRV-OHAC	0.012 (34.9)	0.014 (37.6)	0.013 (36.1)

End of week 3 (high dose)	n = 7	n = 11	n = 18
Brivaracetame	0.598 (60.6)	0.761 (57.7)	0.693 (58.5)
BRV-OH	0.200 (96.4)	0.277 (56.0)	0.244 (72.2)
BRV-AC	0.028 (77.9)	0.048 (68.9)	0.039 (77.6)
BRV-OHAC	0.019 (38.8)	0.029 (43.6)	0.024 (46.5)

Data are presented as geometric mean (coefficient of variation %). All reported p-values can only be interpreted in an exploratory manner, i.e., are nominal

BRV-AC acid metabolite of brivaracetam, BRV-OH hydroxy metabolite of brivaracetam, BRV-OHAC hydroxy acid metabolite of brivaracetam

^aMultiply by 4.713646 to convert concentrations from µg/mL to µmol/L. Metabolite concentrations are expressed in brivaracetam equivalents and use the same conversion factor

^bPatients with a history of focal seizures with or without secondary generalization and no primary generalized seizures at baseline

^cWilcoxon rank-sum test for difference between groups aged < 4 years and 4 to < 16 years, p = 0.17

^dWilcoxon rank-sum test for difference between groups aged < 4 years and 4 to < 16 years, p = 0.60

^eWilcoxon rank-sum test for difference between groups aged < 4 years and 4 to < 16 years, p = 0.48